Home NDC 69452-573 Dextromethorphan HBr
Product NDC 69452-573
11-digit product format 694520573
Labeler code 69452
Product ID 69452-573_5a5dde7e-05b9-13e7-e063-6394a90a197e
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler BIONPHARMA INC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-31
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 15 mg/1
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dextromethorphan HBr
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1090487 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69452-573-17 69452057317 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-573-17) 2026-08-31 No No Current